Trial Information

Phase III Randomized Trial of Comparing CCRT vs. RT Alone for Cervical Cancer Patients Primarily Treated by Radiotherapy and With Clinically Defined Good-prognosis

OBJECTIVES:

Primary Objectives:

•To examine if low-risk, as defined by clinical and radiological parameters, stage IB-IIB
cervical cancer patients treated by cisplatin-based CCRT have greater toxicities but similar
survival rate as those treated by RT alone.

Secondary Objectives:

•To conduct a translational research to find out the molecular markers associated with
radiosensitivity and distant metastasis in cervical cancer patients.

104 cases for each arm.(total 208 cases)

Radiotherapy will start within 3 weeks of randomization.

Chemotherapy:

Cisplatin 40mg/M2 IV infusion weekly concurrently with radiotherapy, up to 6 courses.

Investigation during treatment (for patients on both arms)

1. . Hematology: A complete blood count is required at weekly intervals.

2. . Renal function: Serum creatinine is required before each course of CT.

3. . Body weight and performance status: will be evaluated on the day of weekly visit on
radiotherapy clinics. Performance status is graded by ECOG scale.

4. . Quality of life assessment: assess by EORTC-C30 & CX28 scales at pre-RT, 3-4 weeks
and 6-7 weeks during RT.

Investigation during follow-up:

When radiotherapy (RT) treatment is completed, patients will be followed up as out-patients
basis. The first visit will be within 2 months after last RT. For patients whose tumor
does not regress completely at the end of RT, monthly follow-up for at least 3 months or to
the time of complete regression is recommended. After first follow-up or time of compete
regression of tumor, patients will be followed up at 3-monthly intervals for 2 years,
4-monthly for one year, then 6-monthly.

Quality of life assessment: assess by EORTC-C30 & CX28 scales at 2 months, 4-5 months after
RT, then q 6 months x 2 and yearly for another 2 years.

Dosage modification and toxicity Toxicity must be recorded at each attendance for
chemotherapy and monthly during radiotherapy on the "on study form".

1. . Hematological toxicity: ANC < 1500 /mm3 and/or platelet < 100,000 /mm3 prior to
chemotherapy will require one week delay in treatment until these levels have been
reached. If the parameters are still below requirements 1 week later, administration of
chemotherapy could still be proceeded if 1000 50,000 /mm3
at reduced dose (25% off).

Radiotherapy will not be delayed unless severe infection or a white count less than
1000/mm3

2. . Renal toxicity:

a). Cisplatin: Serum creatinine < 1.5 mg% (creatinine clearance > 70 ml/min): full
dose; 1.6-1.9 mg% (or 0.6-0.8 mg% above base line, or Ccr 50-70 ml/min): 25% off; >
2.0 mg% (or > 1.2 mg% over baseline or 50% decrease of Ccr): no cisplatin

3. . Neurotoxicity: Cisplatin discontinued on Grade 3 neuropathy. 30% dose decrease for
Grade 2 neurotoxicity or ototoxicity

4. . Ototoxicity: Ototoxicity is rare within 4 -6 courses or cisplatin, but if clinical
significant deterioration of hearing loss (grade 3) was noted, cisplatin will be
discontinued. The aged are more susceptible to ototoxicity.

5. . Genitourinary complications Urinary tract infection or radiation cystitis may be
noted during the course of treatment, CT or CT+RT will be withheld in case of grade 3
toxicity

6. Gastroenterological toxicity:

Acute radiation enteritis may prelude continuation or delay either CT or CT+RT