Radiation Dosimetry Study Comparing 2 Different Patient Setups in Anal/Rectal Cancer Patients

Learn more about:
Related Clinical Trial
CRTE7A2-01 TCR-T Cell for HPV-16 Positive Advanced Cervical, Anal, or Head and Neck Cancers Assessment of Patients’ Quality of Sexual Life After Anal Cancer Treatment Neoadjuvant PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced Anal Canal Squamous Carcinoma Patients Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5) Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors Detecting HPV DNA in Anal and Cervical Cancers ANCA II – Quality of Life and Functional Outcome in Patients With Anal Cancer RTX-321 Monotherapy in Patients With HPV 16+ Tumors Anal Injury Screening for High Risk HPV M7824 in Subjects With HPV Associated Malignancies Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer Avastin/[18-F]-5-fluorouracil PET/CT Imaging Feasibility Project Assessment of Health Related Quality of Life in Patients Treated for Rectal Cancer Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies Function Following Laser for Anal Intraepithelial Neoplasia (FLAN) A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination Anal Sphincter Prosthesis in Treating Patients Who Are Undergoing Surgery for Anal or Rectal Cancer Phase 2 Study of ADXS11-001 in Subjects With Carcinoma of the Anorectal Canal Pilot Study to Determine the Safety and Efficacy of Gardasil Against the Human Papilloma Virus (HPV) in HIV-infected Men Assessment of Symptom-Related Cytokines in Lung and Gastrointestinal (GI) Cancer Patients Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT Early Rectal Cancer: Endoscopic Submucosal Dissection or Transanal Endoscopic Microsurgery? Drainage Seton With Flap Versus EAS Preserving Seton in Treatment of Transsphincteric Anal Fistula HPV-SAVE: 9-Valent HPV Vaccine for High-Grade Anal Dysplasia Radiation Dosimetry Study Comparing 2 Different Patient Setups in Anal/Rectal Cancer Patients Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men The HPV-SAVE Study Team: HPV Screening and Vaccine Evaluation in Men Who Have Sex With Men High-Resolution Anoscopy Perceived Discomfort Study Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia Image Fusion PET, CT and 3D-ultrasound Examinations Hybrid Capture 2 Human Papiloma Virus (HPV) High-Risk Anal DNA Test ART: Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV Molecular Genetic and Pathological Studies of Anal Tumors Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer QOL & Functional Outcomes After Combined Modality Tx for Anal CA: Comparison of Conventional vs IMRT A Study of mDCF in Combination or Not With Atezolizumab in Advanced Squamous Cell Anal Carcinoma Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal Cancer Radiochemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma. A Multicenter, Randomized, Phase II Trial of the German Anal Cancer Study Group Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy Screening for HIV-Associated Anal Cancer Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer A Prospective, Open-Label, Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE) Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients With Primary Anal Cancer Prospective Cohort on Quality of Sexual Life Among Men Who Have Sex With Men Treated for Anal Cancer With Concurrent Chemotherapy and Intensity-modulated Radiotherapy Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer SGN-00101 in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia Anal Cancer Radiotherapy Study Radiation Therapy, Mitomycin, and Either Fluorouracil or Cisplatin in Treating Patients With Locally Advanced Anal Cancer Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer Individual Following in Anal Cancer With PET/CT Anal Cancer Screening Study The Prevent Anal Cancer Self-Swab Study Shared Decision Making With Anal Cancer Patients on Radiation Dose Predictive Value of FMISO-PET, FDG-PET-CT, DWI-MRI and DCE-MRI Scans for Patients With Anal Cancer Receiving Radiotherapy +/- Chemotherapy Quality of Life in Patients With Anal Cancer Functional Outcomes Following Anal Cancer Treatment Pembrolizumab in Refractory Metastatic Anal Cancer A Phase I/II Evaluation of ADXS11-001, Mitomycin, 5-fluorouracil (5-FU) and IMRT for Anal Cancer

Brief Title

Radiation Dosimetry Study Comparing 2 Different Patient Setups in Anal/Rectal Cancer Patients

Official Title

Genital Drop Technique With Intensity-Modulated Radiation Therapy (IMRT) in Male Anal and Distal Rectal Cancer Patients: A Dosimetric Comparison

Brief Summary

      The study compares two patient setups (Standard Prone vs. Genital Drop Technique) with
      identical radiation treatment technique and parameters. After the two setups have been
      planned, the treating faculty reviews the setups and will choose the setup he feels that will
      give the patient improved dosimetry to the local regions and hopefully reduce toxicity and
      improve treatment tolerability.
    

Detailed Description

      This is a study of two different setups when treating a patient with standard of care
      radiation doses. The study compares two patient setups (Standard Prone vs. Genital Drop
      Technique) with identical radiation treatment technique and parameters. After the two setups
      have been planned, the treating faculty reviews the setups and will choose the setup he feels
      that will give the patient improved dosimetry to the local regions and hopefully reduce
      toxicity and improve treatment tolerability.

      Patients will not be randomized or stratified by demographic or disease risk assessment, but
      treatment will be tailored to stage specific current standards of care.

      An extra (non standard of care) CT is required to analyze the data.
    


Study Type

Observational


Primary Outcome

The Genital Drop Technique (IMRT-GD) decreased the radiation dose to the testicles scrotal skin and penile shaft compared to standard prone technique.

Secondary Outcome

 Dosimetry comparison details.

Condition

Anal Cancer



Publications

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

Recruitment Information



Estimated Enrollment

14

Start Date

July 2007

Completion Date

June 2009

Primary Completion Date

June 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically proven anal cancer (squamous, basaloid, or cloacogenic carcinoma) or
             distal rectal cancer (adenocarcinoma variants) that traverse the dentate line and are
             eligible for definitive chemoradiation or preoperative radiation therapy,
             respectively.

          -  Any histological grade.

          -  Age: >18 years.

          -  Gender: Male patients with average external genitalia.

          -  Race: Any.

          -  Language: English speaking only.

          -  Performance status: Good (Karnofsky Performance Status of >60%). (ECOG 0-2).

          -  UTMB patients

          -  Stages: Early local disease to locoregionally advanced disease per the 2002 American
             Joint Committee on Cancer (AJCC) Staging System.

          -  Anal Cancer: Stages I-IIIB (see Section 11).

          -  Distal Rectal Cancers that pass the dentate line and into the anal canal only: Stages
             IIA-IIIC (see Section 11).

        Exclusion Criteria

          -  Histological variants other than those listed above in 4.a.

          -  Patients with cystocele or abnormal scrotal edema will be excluded. (Although the
             Genital Drop Technique may specifically benefit this group of patients, however this
             study is to be performed with average patient anatomy).

          -  2002 American Joint Committee on Cancer (AJCC) Staging System. (Anal Cancer: Stage
             IV.; Distal Rectal Cancer: Stage IV, and tumor 2-node 0-metastasis 0 (T1-T2N0M0)
             patients).

          -  Performance status: Poor (Karnofsky Performance Status of <60%). (ECOG 3-4).

          -  Non-English speaking patients.

          -  Prior pelvic radiation.

          -  Prior pelvic malignancy.

          -  Anal cancer/rectal cancer surgery, except for biopsy at study site.

          -  Patient's mental condition and social support is such that he can neither understand
             the nature of the protocol nor comply with its requirements.
      

Gender

Male

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Grant R. Seeger, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00693173

Organization ID

07-049


Responsible Party

Sponsor

Study Sponsor

The University of Texas Medical Branch, Galveston


Study Sponsor

Grant R. Seeger, MD, Principal Investigator, The University of Texas Medical Branch at Galveston


Verification Date

February 2013