Chemo Alone or in Combination With Radiation in Unresectable Cholangiocarcinoma

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Brief Title

Chemo Alone or in Combination With Radiation in Unresectable Cholangiocarcinoma

Official Title

Phase III Randomized Trial of High Dose Chemoradiation and Systemic Chemotherapy vs Systemic Chemotherapy Alone in Patients With Unresectable Nonmetastatic Cholangiocarcinoma

Brief Summary

      The study evaluates impact of high dose radiation on overall survival in patients with
      unresectable nonmetastatic cholangiocarcinoma. The study randomizes patient between systemic
      chemotherapy alone and systemic chemotherapy and high dose radiation
    

Detailed Description

      Currently the standard of care of unresectable non-metastatic cholangiocarcinoma is
      chemotherapy which has a median survival of 11.7 months (ABC-02 study). While this study
      included almost 60% of patients with cholangiocarcinomas (intrahepatic, extra hepatic and
      hilar), almost 73-76% of patients in each arm had metastases to begin with. And while the
      overall survival of the entire cohort was significantly improved by gemcitabine plus
      cisplatin compared to cisplatin alone, the hazard ratios for intrahepatic {0.57 (0.34-0.94)},
      extra hepatic {0.73 (0.43-1.23)} and hilar cholangiocarcinomas {0.59 (0.32-1.09)} were all
      insignificant. Even though concurrent chemoradiation+/= brachytherapy has been used for
      management of cholangiocarcinomas for more than 3 decades the lack of level I evidence
      prevents from it being recommended as the first line management across multidisciplinary
      clinics.

      While either modality alone rarely yields survival of more than 12 months, recent reports of
      improved median survival with combination of high dose radiation and systemic chemotherapy
      necessitates investigation into role of combination of high dose (chemo) radiation and
      systemic chemotherapy.

      All patients with diagnosis of nonmetastatic unresectable cholangiocarcinoma who fulfill the
      study eligibility criteria will be evaluated for study participation. Patients will undergo
      upfront randomization into one of the study arms (systemic chemotherapy alone vs Systemic
      chemotherapy+ High dose radiation) The study stratification criteria will be done according
      the primary site i.e. Intrahepatic vs Extrahepatic.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Overall Survival

Secondary Outcome

 loco-regional progression free survival

Condition

Cholangiocarcinoma

Intervention

High Dose Radiation

Study Arms / Comparison Groups

 Systemic Chemotherapy
Description:  Irrespective of arm allocation Baseline Positron Emission Tomography(PET) scan and hepatic function assessment will be done. Those randomized to this arm will receive systemic chemotherapy delivered on day 1 and 8 every 3 weekly, with gemcitabine 1000 mg/m2 and cisplatin 25 mg/m2. After first 4 cycles patients will undergo repeat Contrast Enhanced Computed Tomography(CECT)/PET scan. If CECT/PET scan shows stable/ responding disease then patients will continue to receive the same chemotherapy. In case of locally progressive/ systemic disease on chemotherapy patients may be considered for second line palliative chemotherapy or best supportive care. The use of radical chemoradiation is not allowed on disease progression in this arm. However palliative radiation may be used.

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

155

Start Date

May 2015

Completion Date

June 2022

Primary Completion Date

June 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Age >18 years

          -  Performance Status 0-2

          -  Tissue diagnosis of adenocarcinoma of the biliary tract. Wherever tissue diagnosis is
             not feasible in spite of repeated attempts a multidisciplinary consensus on
             clinicoradiological diagnosis of cholangiocarcinoma (CA 19-9= 100mg/ml with a
             radiological evidence of malignant stricture) should be made and patients consent
             should be available for treatment without tissue diagnosis.

          -  Unresectable disease as determined by hepatobiliary surgical team.

          -  No evidence of peritoneal or distant metastasis.

          -  No radiological evidence of paraaortic nodal disease.

          -  Child A or Child B (score 7)

          -  Ability to tolerate radical treatment.

        Exclusion Criteria:

          -  Multicentric intrahepatic cholangiocarcinoma (however adjacent satellite lesions are
             permitted)

          -  Inability to deliver safe radiation due to high tumor/ liver ratio.

          -  Active cholangitis.

          -  Expected Survival<6 months.

          -  Unresolved biliary tract obstruction.

          -  Inability in deliver systemic chemotherapy (persistent bilirubin>3)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Supriya Chopra, MD, 09930958309, [email protected]

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT02773485

Organization ID

TMC IRB 1457


Responsible Party

Principal Investigator

Study Sponsor

Tata Memorial Hospital


Study Sponsor

Supriya Chopra, MD, Principal Investigator, ACTREC,Tata Memorial Centre


Verification Date

October 2020