Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis.

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Brief Title

Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis.

Official Title

Effectiveness of Adjuvant Radiotherapy in Patients With Oropharyngeal and Floor of Mouth Squamous Cell Carcinoma and Concomitant Histological Verification of Singular Ipsilateral Cervical Lymph Node Metastasis (pN1-state)

Brief Summary

      Radiotherapy with or without adjuvant chemotherapy represents an important column of modern
      therapy in advanced squamous cell originated tumours of the head and neck. However to date no
      studies are available which study the effectiveness of radiotherapy in patients with resected
      small tumours (T1, T2) and concomitant ipsilateral metastasis of a single lymph node (pN1)
      for general treatment recommendation. The present study is designed as non-blinded,
      prospective, multicenter randomized controlled trial (RCT) for comparison of overall-survival
      as primary clinical target in patients receiving radiation therapy vs. patients without
      adjuvant radiation following curative intended surgery. Aim of the study is to enroll 560
      adult males and females for 1:1 randomization to one of the two treatment arms
      (radiation/non-radiation. Secondary clinical endpoints are as follows: Incidence and time to
      tumor relapse (locoregional relapse, lymph node involvement and metastatic spread), Quality
      of life as reported by EORTC (QLQ-C30 with H&N 35 module) and time from operation to
      orofacial rehabilitation.
    

Detailed Description

      Background

      Prevailing curative intended therapeutic strategies combine radical resection of the tumor
      mass with a safety margin followed by radiation of the original tumor site and adjacent
      locoregional lymphatic drainage areas. To date selection of the individual therapeutic
      pattern is essentially guided by pre- and post-therapeutic TNM staging parameters.
      Exceptionally for advanced tumors postoperative radiotherapy and optional combination with
      (radiosensitizing) chemotherapeutic agents is favorable and recommended. Interdisciplinary
      guidelines stated the following detailed recommendations for application of adjuvant
      radiation therapy:

        -  non in sano resection if reoperation is impossible (R1-, R2-status)

        -  primary tumor status > pT2 and pN2, pN3

        -  extranodular spread of the disease

        -  lymphangiosis carcinomatosa

        -  facultative: pN1 According to these recommendations postoperative radiotherapy of
           advanced tumors is feasible while for small tumors indication for adjuvant therapy
           depends on further parameters like the pN findings. Here verification of more than one
           singular lymph node metastasis (pN2) leads to additional radiotherapy. In tumors with a
           diameter less than 4 cm (T1, T2) and concomitant verification of a single lymph node
           metastasis no explicit therapeutic recommendation is offered to date displaying
           radiation an optional complement for these cases. Meta-Analysis revealed only a few
           studies taking this special group of patients into account stating adjuvant radiotherapy
           an additional risk factor for overall survival, however small patient numbers,
           inhomogeneous group distribution and ambiguous risk factors exhibited a significant
           bias.

      The methodological key problems which had to be addressed in the protocol were the following:

        -  extremely different treatment arms with strong preferences for one or the other therapy
           arm

        -  low number of eligible patients per center

        -  Inclusion criterion (pN1) including a pathological diagnosis and surgical treatment with
           possible differences

        -  Radiation treatment as one arm with special need for quality control Thus the idea of
           presenting this paper is, to discuss how these specific issues were taken care of.

      Methods/Design Study Design The study is designed as a non-blinded, prospective, randomized
      controlled clinical trial.

      Study objectives Objective of the clinical study will be the investigation of two different
      patient collectives (irradiated/unirradiated) with pT1/2 primary and verification of a
      singular ipsilateral lymph node metastasis in parallel design in order to evaluate a possible
      significant benefit of radiation therapy. Investigation of further biological parameters will
      be concomitantly performed to assess a possible prediction of tumor progression and to
      evaluate surrogate markers of radioresistance. The following null hypothesis forms the basis
      of the present study: Radiation therapy will have no influence on the overall survival in
      patients with pT1/2, pN1 primary tumor. Secondary outcome variables include incidence and
      time to tumor relapse (locoregional relapse, lymph node involvement and metastatic spread),
      Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module) and time from operation to
      orofacial rehabilitation.

      Patients

      Males and females with histological verified diagnosis of a primary squamous cell carcinoma
      of the oral cavity or the oropharynx are eligible. Inclusion criteria are as follows:

        -  maximum tumor diameter less than 4 cm in the pathohistological specimen irrespective of
           histological grading (pT1 or pT2)

        -  concomitant histological verification of a singular ipsilateral lymph node metastasis
           less than 3cm in diameter (pN1) without penetration of the lymph node´s capsule and
           without presence of lymphangiosis carcinomatosa

        -  radical resection of the tumor within adequate resection margins (R0)

        -  written informed consent from the patient

        -  adequate performance status ECOG Index ≤ 2 Patients with an age less than 18 and
           pregnant women are to be excluded. Further criteria of exclusion are reported drug
           addiction or intake of remedies with potential influence on compliance or impaired
           judgment. In addition patients with mental disorders or conceivable physical, familial
           or job related embarrassments which may preclude the patient to realize the study
           schedule. Moreover patients with physical impairment by inadequate treatment of derailed
           diseases e.g. untreated diabetes mellitus or acute heart insufficiency (ECOG-Index >2).

      Study interventions Radiotherapy should begin within 6 weeks after the last surgical
      intervention, whereas a minimal postoperative healing period of at least 8 days should be
      respected. Causes for delay of intervention are to be documented. Application of radiotherapy
      defines group 1 versus the non irradiated group (group 2).

      Surgical treatment The primary is considered radically resected if macroscopic and histologic
      evaluation approved resection margins without tumor residuals (R0 status). For surgical
      proceeding a safety margin of at least 1cm is established. For surgical considerations of
      lymph node resection the tumor localization is divided in level I (below occlusional plane)
      and level II (above occlusional plane) respecting pre-, postcanine or retromolar finding in
      addition. Classification of cervical regions follows the recommendations of Robbins from
      2002. Hence, the neck is divided into 6 different sections.

      Ipsilateral N0 state of cervical lymph nodes Pre- and postcanine localized tumors of level I
      require a selective neck dissection of the cervical level 1-3. In level I tumours of the
      retromolar triangle selective neck dissection of ipsilateral level 1-5 is proceeded. In level
      II tumors no selective neck dissection is considered.

      Contralateral N0 state No neck dissection is performed Ipsilateral N1- N2 state For
      retromolar localized level I tumors a modified radical neck dissection is performed. If the
      tumor is localized pre- or postcanine intraoperative frozen sections of level 1 lymph nodes
      are evaluated. Positive intraoperative results lead to modified radical resection of level
      1-5 lymph nodes. In case of negative results resection of the lymph nodes within level 1-3 is
      affiliated. Negative instantaneous sections in level II tumors require no lymph node
      dissection. All metastatic affection of level II-III lymph nodes necessitates modified
      radical neck dissection.

      Contralateral N1-N2 state Instantaneous section is performed for level 1 lymph nodes.
      Modified radical neck dissection is performed in positive, resection of level 1-3 lymph nodes
      is conducted in negative results. Metastases spread in level 2-3 lymph nodes acquire modified
      radical neck dissection.

      Lymph node therapy of midline tumors Midline tumors may require bilateral resection of lymph
      node echelons at risk. Bilateral modified neck dissection is performed for staging purposes
      if indicated. Contralateral lymph node dissection of the level 1-3 in precanine localized
      tumors is mandatory.

      Technical conditions and practical execution of radiation therapy Radiotherapy is performed
      by photons of 4 to10 MeV or/and electrons of 6 to 15 MeV maximum energy. Individual 3
      dimensional dose distribution calculation is mandatory and has to be made on the basis of a
      postoperative native computer tomogram. All patients are to be treated while immobilized by a
      custom made face mask made of thermoplast or equivalent. Clinical target volume definition
      compasses the original tumor site with a safety margin of 2 cm in each direction.

      Floor of mouth, anterior tongue Irradiation of the anterior two third of the tongue as well
      as the anterior floor of mouth is irradiated by lateral opposing beams, while the maxilla is
      separated by insertion of a bite block.

      Oropharynx, buccal plane, soft palate confined to one side For tumors of the buccal plane,
      the tonsilla, the soft palate and the retromolar triangle two types of planning target volume
      may be applied.

      In case of negative contralateral cervical nodes an ipsilateral target volume for the primary
      is defined including the lymph nodes of group IB, IIA and IIB. Irradiation technique
      recommended is a two wedge fields typically angulated by 90 to 120 degrees. The ipsilateral
      node levels III-V are treated by an anterior portal down to clavicle. The contralateral neck
      is spared.

      Tumors of the lateral and dorsal pharyngeal wall and their lymphatic drainage (levels II,
      III, IV and V) are irradiated bilaterally with opposing beams. Irrespective of technique used
      3 D conformal dose shaping is highly recommended.

      Dosage and fractionation Target volume definition and dosage has to be performed according to
      the rules of ICRU report 50. At the primary tumor site and at involved lymph node levels a
      total dose of 59.4 Gy in 33 fractions within 45 days is scheduled. At electively irradiated
      volumes a total dose of 50.4 Gy in 28 fractions is scheduled. All fractions of 1.8 Gy each
      are given five times per week. In case of machine break down an additional fraction per week
      is recommended with an at least 6 h interval between two fractions on the same day or on
      Saturday. Total treatment duration (including planned/unplanned interruptions) is to be
      documented in days. Any patient must be available for intent to treat analysis.

      Instead of the classical portal arrangements and dose distributions intensity modulated
      radiotherapy using an inverse calculation algorithm may be used in experienced centers. Dose
      constraints for normal tissues are at the discretion of the participating centers. Dose
      specification according to the RTOG protocol H 0022 is recommended. Details are given in a
      standard operation procedure.

      Follow-Up Recruitment phase will be 4 years with physical examination, ECOG index, and
      quality of life questionnaire will be performed 3, 6 and 12 months after end of radiation.
      Further follow up will be performed annually up to 5 years to obtain sufficient clinical
      data.

      Randomization and Sample Size The present study setup consists of a two armed randomized
      controlled trial (RCT) as primary study aim. Patients rejecting their participation to a
      randomized approach and preference to a certain procedure (radiation/no radiation) will be
      included into a prospective observational study after given informed consent. This parallel
      constructed observational trial will be performed with a maximum of consistency to treatment
      and observation compared to the RCT. In case of positive attendance the patients will be
      randomized, stratified by the criteria of adequate lymph node therapy (yes/no) as formulated
      by the DOESAK. Randomization to both groups (radiation group/control group) will be 1 to1.
      Patients will be recruited over a period of 4 years and follow-up will be annually until the
      trial ends, i.e. at least for 5 years for each patient. Sample size calculation will be
      performed for the two-sided log rank test at a significance level of 5%. Assuming an
      exponential distributed survival with survival probabilities after 5 years of 45% within the
      control group and of 55% within the radiation group (results observed from the DOESAK
      collective) and a drop-out rate of 5% per year, 280 patients per group are required to detect
      a significant difference in overall survival with a power of 70%. In case of impaired patient
      recruitment within the randomized trial, it is intended to recruit at least 280 patients per
      group in the observational study.

      Analysis of RCT and observational trial

      Initiation of this trial is only arguable with a realistic chance of statistical evaluation
      of an adequate count of randomized patients. Hence an intermediate assessment of attendance
      to randomization will be performed after the first and the second year of recruitment. If
      less than 5% of patients agreed to randomization within the first and 10% within the second
      year RCT will be stopped and the study is continued solely as observational trial (see table
      1). Intermediate assessment is performed with presumption of accelerating involvement to
      achieve a minimum of 20% randomized patients after the recruitment phase. As consequence to
      the study design two different collectives (randomized collective/ collective with preferred
      form of therapy) will exist. The following scenarios of analysis are possible:

        1. If a sufficient number of patients was randomized, treatment comparison will be
           performed within the randomized collective. The non-randomized collective will be used
           to evaluate the external validity of observed treatment effects.

        2. If no sufficient number of patients could be randomized, all recruited patients will be
           analyzed. Descriptive comparison of treatment groups will be performed for all baseline
           variables. All analyses will be performed with adjustment to baseline variables
           affecting survival. Results have to be interpreted with respect to any group differences
           in baseline variables.

      Outcome measurements Primary clinical endpoint Overall survival Secondary clinical endpoints
      Incidence of tumor relapse

        -  Time to occurrence of lymphatic metastases

        -  Time to occurrence of local relapse

        -  Time to occurrence of distant metastases

        -  Tumor related death due to local tumor progression or metastatic spread Life quality

             -  Time to provisional orofacial rehabilitation

             -  Time from operation to first intermediate prosthesis intake

             -  Time from operation to definitive prosthesis application

             -  Life Quality report (EORTC QLQ-C30 with H&N 35 module)

      Overall survival will be evaluated in a Cox proportional hazard model with treatment and
      adequate lymph node therapy (yes/no) as covariates. Further covariates may be considered if
      they affect survival.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Primary study object: overall survival

Secondary Outcome

 Time to occurrence of local relapse

Condition

Oropharyngeal Cancer

Intervention

Radiation therapy

Study Arms / Comparison Groups

 no irradiation
Description:  Patients within this arm only receive curative intended radical surgery

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Radiation

Estimated Enrollment

560

Start Date

October 2009

Completion Date

December 2018

Primary Completion Date

December 2013

Eligibility Criteria

        Inclusion Criteria:

          -  histological diagnosis of a primary squamous cell carcinoma of the oral cavity or the
             oropharynx

          -  maximum tumor diameter less than 4 cm in the pathohistological specimen irrespective
             of histological grading (pT1 or pT2)

          -  concomitant histological verification of a singular ipsilateral lymph node metastasis
             less than 3cm in diameter (pN1) without penetration of the lymph node´s capsule and
             without presence of invasion of lymphatic vessels (lymphangiosis carcinomatosa)

          -  radical resection of the tumor within adequate resection margins (R0)

          -  written informed consent from the patient

          -  adequate performance status ECOG Index ≤ 2

        Exclusion Criteria:

          -  an age less than 18 years old

          -  pregnant women

          -  reported drug addiction

          -  intake of remedies with potential influence on compliance or impaired judgment

          -  patients with mental disorders or conceivable physical, familial or job related
             embarrassments which may preclude the patient to realize the study schedule

          -  inadequate performance status ECOG Index > 2
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Wilfried Wagner, MD, DMD, PHD, 0049-6131-173752, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT00964977

Organization ID

DOESAK-pN1-108399


Responsible Party

Principal Investigator

Study Sponsor

Johannes Gutenberg University Mainz

Collaborators

 Deutsche Krebshilfe e.V., Bonn (Germany)

Study Sponsor

Wilfried Wagner, MD, DMD, PHD, Study Director, 


Verification Date

November 2012