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Comparing Standard Concurrent Chemo-radiation to Neoadjuvant Chemotherapy Then Surgery or Radiation in Patients Stage Ib2-early IIb Cervical Carcinoma


Phase 3
18 Years
60 Years
Open (Enrolling)
Female
Cervical Cancer

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Trial Information

Comparing Standard Concurrent Chemo-radiation to Neoadjuvant Chemotherapy Then Surgery or Radiation in Patients Stage Ib2-early IIb Cervical Carcinoma


According to FIGO classification of cervical cancer, stage Ib2 was classified as clinically
visible lesion more than 4.0 cm in greatest dimension and stage IIb was classified tumor
invades parametrium must not to pelvic wall. These were the common stages in Thai cervical
cancer patients,and made a troublesome effect to Thai women. According to this study,stage
early IIb with 1/3 of parametrium involvement. Mostly these two stage was treated with
concurrent chemoradiation, challenging the possibility of late sequelae of radiation effect.
This specific group of patients can be avoid the referred side effect by using neoadjuvant
chemotherapy followed by radical hysterectomy with pelvic lymphadenectomy and para-aortic
node sampling in operable cases (at least partial response- PR) and concurrent
chemoradiation (CCR) in inoperable cases (less than PR). Due to high risk type of these
subspecific group, combination chemotherapy instead of single chemotherapy was used as CCR.
However in operable cases with identified poor prognostic factor should be receive post
operative radiation as the usual manner.


Inclusion Criteria:



- Cervical cancer patients with FIGO stage Ib2-early IIb

- Pathological proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell
carcinoma

- ECOG performance status 0-1

- No previous treatment for cervical cancer

- Acceptable hematological,renal,liver function

Exclusion Criteria:

- Previous history of cancer

- Underlying disease not fit for surgery

- Psychological problem

- Obvious pelvic/para-aortic node involvement

- Pregnancy

- HIV positive

- History of bowel obstruction

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival comparison between experimental treatment group and standard treatment group

Outcome Time Frame:

9 Years

Safety Issue:

Yes

Principal Investigator

Saibua B. Chichareon, MD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thai Gynecologic Oncology Collaborative Group (TGOC)

Authority:

Thailand: Ethical Committee

Study ID:

TGOC-03

NCT ID:

NCT01000415

Start Date:

June 2009

Completion Date:

June 2018

Related Keywords:

  • Cervical Cancer
  • Stage Ib2-early IIb of cervical cancer
  • Neoadjuvant chemotherapy
  • Cisplatin plus gemcitabine
  • Radical hysterectomy with pelvic lymphadenectomy
  • Quality of life
  • Stage Ib2-IIb of cervical cancer patients
  • Uterine Cervical Neoplasms

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