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Chemo Alone or in Combination With Radiation in Unresectable Cholangiocarcinoma

T

Tata Memorial Hospital

Status and phase

Enrolling
Phase 3

Conditions

Cholangiocarcinoma

Treatments

Drug: Systemic chemotherapy
Radiation: High Dose Radiation

Study type

Interventional

Funder types

Other

Identifiers

NCT02773485
TMC IRB 1457

Details and patient eligibility

About

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

Full 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.

Enrollment

155 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

155 participants in 2 patient groups

Systemic Chemotherapy
Active Comparator group
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.
Treatment:
Drug: Systemic chemotherapy
Chemotherapy and radiation
Experimental group
Description:
In those randomized to radiation arm with receive high dose radiation with Intensity Modulated Radiation Therapy in addition to systemic and concurrent chemotherapy. The gross tumor will comprise the high dose volume. The adjacent areas of suspected microscopic disease will form the low dose volume. When only external radiation is used the aim will be to deliver 52.5-60 Gy/ 25 fractions to the gross disease and 45 Gy/ 25 fractions to suspected microscopic disease along with weekly gemcitabine (300 mg/ m2) .
Treatment:
Radiation: High Dose Radiation
Drug: Systemic chemotherapy

Trial contacts and locations

1

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Central trial contact

Supriya Chopra, MD; Supriya Chopra, MD

Data sourced from clinicaltrials.gov

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